PrediabetesPhase 2NCT02191644
Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes
A Phase 2 study testing Dietary intervention-refined rice and Dietary intervention-whole grains and legumes in people with Prediabetes and Type-2 Diabetes, run by Yonsei University at 1 site in South Korea.
Trial summary
This study examined whether dietary-induced reductions in lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma affected metabolic profiles in PBMCs and plasma. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Prediabetes, Type-2 Diabetes
- What is being tested?
- Dietary intervention-refined rice and Dietary intervention-whole grains and legumes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects who had IFG (100≤ fasting glucose <126 mg/dL)
- or newly diagnosed type-2 diabetes (fasting glucose ≥126 mg/dL)
Who cannot join
- current and/or past history of cardiovascular disease including angina
- liver or kidney dysfunction
- thyroid or pituitary disease
- pregnancy or lactation
- taking medications or supplements
Trial locations and contacts
1 site in 1 country.
About this study
This study examined whether dietary-induced reductions in lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma affected metabolic profiles in PBMCs and plasma.
Read the detailed description
Eighty nonobese patients (aged 40-70 years) with prediabetes or newly diagnosed type-2 diabetes were randomly assigned to a control group (normal diet with refined rice) or a whole-grain group (replacement of refined rice with whole-grains and legumes). This dietary intervention replaced approximately 7% of carbohydrate-derived energy with approximately 4% of protein-derived energy and approximately 3% of fat-derived energy.
- Conditions
- Prediabetes, Type-2 Diabetes
- Being tested
- Dietary intervention-refined rice, Dietary intervention-whole grains and legumes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention-refined riceDietary supplement
Subjects in the control group maintained the usual refined-rice diet.
Dietary intervention-whole grains and legumesDietary supplement
Subjects in the whole-grain group replaced refined rice with a mix of 1/3 legumes, 1/3 barley, and 1/3 wild rice three times per day, and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.
| Study group | Role | What they receive |
|---|---|---|
| Refined rice | Placebo comparator | Not described Receives: Dietary Supplement: Dietary intervention-refined rice |
| Whole grains and legumes | Experimental | Not described Receives: Dietary Supplement: Dietary intervention-whole grains and legumes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lp-PLA2 Activity in Plasma
Measured: Change from baseline in Lp-PLA2 at 12 weeks
Lp-PLA2 Activity in PBMC
Measured: Change from baseline in Lp-PLA2 at 12 weeks
Secondary outcomes (1)
PBMC metabolites
Measured: Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Ho Lee, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191644
- Sponsor's protocol ID
- PBMC_Lp-PLA2_metabolite
- Status last verified
- Jul 2014
- First submitted
- 14 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim M, Song G, Kang M, Yoo HJ, Jeong TS, Lee SH, Lee JH. Replacing carbohydrate with protein and fat in prediabetes or type-2 diabetes: greater effect on metabolites in PBMC than plasma. Nutr Metab (Lond). 2016 Jan 19;13:3. doi: 10.1186/s12986-016-0063-4. eCollection 2016.
PubMed 26788114
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes
- ClinicalTrials.gov ID
- NCT02191644
- Acronym / sponsor ID
- PBMC_Lp-PLA2_metabolite
- Conditions
- Prediabetes, Type-2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examined whether dietary-induced reductions in lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma affected metabolic profiles in PBMCs and plasma.
Detailed description
Eighty nonobese patients (aged 40-70 years) with prediabetes or newly diagnosed type-2 diabetes were randomly assigned to a control group (normal diet with refined rice) or a whole-grain group (replacement of refined rice with whole-grains and legumes). This dietary intervention replaced approximately 7% of carbohydrate-derived energy with approximately 4% of protein-derived energy and approximately 3% of fat-derived energy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refined rice | Placebo comparator | Dietary Supplement: Dietary intervention-refined rice |
| Whole grains and legumes | Experimental | Dietary Supplement: Dietary intervention-whole grains and legumes |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects who had IFG (100≤ fasting glucose <126 mg/dL)
- or newly diagnosed type-2 diabetes (fasting glucose ≥126 mg/dL)
Key exclusion criteria (5 listed)
- current and/or past history of cardiovascular disease including angina
- liver or kidney dysfunction
- thyroid or pituitary disease
- pregnancy or lactation
- taking medications or supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention-refined riceSubjects in the control group maintained the usual refined-rice diet. | Dietary supplement | Refined rice |
| Dietary intervention-whole grains and legumesSubjects in the whole-grain group replaced refined rice with a mix of 1/3 legumes, 1/3 barley, and 1/3 wild rice three times per day, and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake. | Dietary supplement | Whole grains and legumes |
Primary outcome
Lp-PLA2 Activity in Plasma
Time frame: Change from baseline in Lp-PLA2 at 12 weeks
Lp-PLA2 Activity in PBMC
Time frame: Change from baseline in Lp-PLA2 at 12 weeks
1 secondary outcome
PBMC metabolites
Time frame: Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Derived from this study: PubMed 26788114Kim M, Song G, Kang M, Yoo HJ, Jeong TS, Lee SH, Lee JH. Replacing carbohydrate with protein and fat in prediabetes or type-2 diabetes: greater effect on metabolites in PBMC than plasma. Nutr Metab (Lond). 2016 Jan 19;13:3. doi: 10.1186/s12986-016-0063-4. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Ho Lee, PhD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dietary intervention-refined rice and Dietary intervention-whole grains and legumes in people with Prediabetes and Type-2 Diabetes, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lp-PLA2 Activity in Plasma (time frame: Change from baseline in Lp-PLA2 at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02191644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.